Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 20, 2021

Primary Completion Date

September 19, 2025

Study Completion Date

December 19, 2025

Conditions
Ovarian Epithelial Cancer Stage IOvarian Epithelial Cancer Stage IIOvarian Epithelial Cancer Stage IIIStage I Fallopian Tube CancerStage II Fallopian Tube CancerStage III Fallopian Tube CancerPeritoneal Carcinoma
Interventions
PROCEDURE

Second look laparoscopy reassessment surgery (SLLRS)

Performed less than 12 weeks after intravenous chemotherapy cycles are completed.

DRUG

HIPEC with Carboplatin

"Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.~Patients who exhibit the following will not receive the HIPEC procedure:~* Extraperitoneal disease noted at the time of the second look procedure~* Macroscopic intraperitoneal disease which is not resectable to R1~* Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion~* Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC~Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research."

OTHER

FACT-O Quality of Life Questionnaire

Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.

Trial Locations (1)

27157

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER